Clinical Pharmacology Shared Resource Summary The objective of the Clinical Pharmacology Shared Resource is to advance clinical cancer research by providing clinical pharmacology services to Masonic Cancer Center (MCC) members. This objective is closely aligned with the goals of the MCC to translate research findings into safe and highly effective cancer treatments. In the last CCSG renewal, the Clinical Pharmacology Shared Resource was supported as a developing shared resource. In this application, it is included as a full shared resource. This Shared Resource provides 1) drug analysis services and 2) consulting services for pharmacokinetics, pharmacodynamics, and pharmacogenetics. The Clinical Pharmacology Shared Resource is affiliated with and benefits from the diverse research foci of the Department of Experimental and Clinical Pharmacology in the College of Pharmacy' Clinical Pharmacology Analytical Laboratory (CPAL). The MCC's Clinical Pharmacology Shared Resource is led by Associate Professor, Mark Kirstein, PharmD, who oversees the laboratory and provides the consulting services, and has been an MCC member for over 15 years. Personnel in the CPAL develop and validate assays to measure drug and metabolite concentrations using HPLC, GC-MS, and LC-MS/MS and to assure accurate measurement across broad ranges of concentrations. The Shared Resource processes, stores, and ships samples for local and national pharmacology studies. Dr. Kirstein provides consulting services to support the design, conduct, and analysis of clinical pharmacology studies and conducts pharmacokinetic, pharmacodynamic, and pharmacogenetic analyses. These services are highly cost efficient because most clinical investigators cannot afford to purchase the expensive analytical equipment needed for drug analysis, may not have laboratory staff trained in assay development and validation, and in some cases may not have laboratories that can process and store blood samples for pharmacokinetic or pharmacodynamic studies. In addition, most clinical investigators do not have the expertise to conduct pharmacokinetic analyses or the financial resources to hire out these analyses. Therefore the Clinical Pharmacology Shared Resource is providing important, accessible, and value-added services to MCC members. Under the leadership of Dr. Kirstein, the Shared Resource has consulted on and supported studies led by MCC researchers and developed assays to detect more than a dozen cancer drugs and their metabolites. Dr. Kirstein has extensive research experience in clinical pharmacology, with expertise in oncology. Day-to-day operations of the CPAL are overseen by Mr. James Fisher, who has 32 years of analytical experience and has managed the Laboratory since 2003. As a result of its robust support and services, use and recognition of the Clinical Pharmacology Shared Resource have increased among MCC members in the previous period.